Senior Service Quality Engineer

Job Description

Due to significant growth, Abiomed is working to develop and enhance Commercial and Service and Repair (S&R) capabilities globally, including quality support to these functions. The seasoned individual contributor will be responsible for supporting multiple workstreams in support of this core initiative, focused on implementation of J&J standards compliance for Abiomed field S&R. In addition, the incumbent will be performing all quality related operational activities for S&R as well as support the distributor control process.

• Provides direct quality support for distributor controls related or S&R Operations owned escalation, non-conformance, CAPA and change control processes in Europe, Middle East, and Africa and indirectly to other global regions.
• Supports distributor controls and S&R operations during internal and external auditing and inspection.
• Supports implementation of processes, systems, resources, and SOPs, for the organization aligning with the J&J policies, J&J standards, applicable regulations and training requirements. Identifies risks, develops proposals and options, and builds consensus with key stakeholders on the determined solutions.
• In partnership with S&R Operations and Commercial implements the aligned processes and procedures at Abiomed to ensure compliant, efficient, and effective Commercial Quality operations in support of substantial growth forecast for the Abiomed business.
• Ensures appropriate self‑training is planned and achieved to support compliant operations within Commercial Quality. Ensures technical and business self‑development through robust development planning and execution.
• Other activities as required by management.

Requirements

• 5+ years of work experience in a highly regulated industry with the ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and internationally. The ideal candidate is an independent learner and critical thinker with an eye for detail.
• A key feature of this role is the high degree of change management that will occur through the assignment.
• Technical knowledge in applicable regulations, quality systems and operations for medical device service and repair and distribution activities including distribution, storage, transportation.
• This role requires a diverse business background, with specific quality and regulatory compliance competencies in the areas of medical device manufacturing, medical device capital equipment service and repair.
• Experience in positions of increasing responsibility supporting multi‑site, global organizations, with broadly based quality or operations experience inclusive of non‑conformance, CAPA, change control and audit/inspection management.
• Must possess a diverse business background, with specific quality, regulatory and regulatory compliance competencies in the areas of commercial quality, supplier quality, storage, and distribution.
• Experience with the global demands of the role specifically: multi‑cultural / multi‑country locations and healthcare regulatory requirements.

Other required skills

• Builds consensus and impacts outcome without always having line authority and can negotiate trade off decisions across the organization. Must have strong collaboration and influence management skills to partner effectively across functions and operating units.
• Strong analytical and strategic skills with a bifocal approach – ability to zoom‑in/zoom‑out for strategic and tactical, high‑level, and detailed.
• Knowledge of Quality IT Systems.
• Decisive, organized, and able to lead people within a complex global environment.
• Excellent communication / presentation skills, able to inspire trust and quickly build credibility within the Quality & Compliance, S&R, Supply Chain, and Commercial organizations.
• “Hands‑on” operational orientation focused on the customer. Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change.
• High tolerance for ambiguity. Makes the complex clear and easily understood by others.
• Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally. Engages in open and honest communications to ensure effective change management.
• Fluent in German and English.

Preferred Knowledge

• IT Systems and Computer System Validation
• Six Sigma methodology
• EN ISO 13485
• EN ISO 14971
• QSR 21 CFR 801; 803; 806; 807; 820; 821; 830; 860
• EU MDR 2017/745 & Directive EEC/93/42
• MDSAP

Education

Required: A minimum of a bachelor’s degree in engineering or scientific discipline is required. An advanced degree in a related field or equivalent direct work experience in Service & Repair and/or Quality Compliance is also an asset.

Preferred: Master’s degree in business, science, engineering, or a related scientific discipline.